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Impact Of The Probable Incorporation Of An Additional Step (Of Public Interest) In Indian Injunction Jurisprudence

by Intellectual Property Watch 8 Comments

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By Swarup Kumar
From the content of the recently decided Roche v Cipla 2008 (37) PTC 71(Del) interim order issued by Justice S. Ravinder Bhatt of Delhi High Court, it appears that an additional step, i.e., a fourth step of public interest – over and above the three-step test laid down in historic judgment in American Cyanamid Co v Ethicon Ltd, 1975 (1) All. ER 504 – has at least for the time being been incorporated into the Indian jurisprudence for deciding the grant or non-grant of interim or ad-interim injunctions vis-à-vis essentially pharmaceutical patent infringement issues.

In the Roche v Cipla case, Justice Bhatt ruled that “Courts while deciding applications seeking interim injunction, involving claims for infringement of patents, especially when life-saving drugs are involved, have to strike a balance between the imponderables such as the likelihood of injury to unknown parties and the potentialities of risk of denial of remedies.”

The Indian courts have in general applied the well-established three-step test of American Cyanamid in order to decide whether to grant an ad-interim injunction against an infringer or not. In determining whether to grant an interim injunction in accordance with the Cyanamid principles, a court ought to consider the following three points: (1) That the claimant can show that there is a serious issue to be tried; (2) that the court considers where the balance of convenience lies; and (3) if there is no imbalance, then the status quo is preserved.

On the other hand, the Roche v Cipla order clearly implied that a fourth step, i.e., taking into consideration whether the interest of the general public will be hampered, ought from now onwards also be taken into consideration by the Indian courts with respect to the cases involving grant or non-grant of interim injunctions against a so-called infringer (generic) when pharmaceutical patent infringement issues are involved in India.

In some respects, it makes sense that in a country like India (where purchasing capacity of the general public is extremely low), the interest of the public be taken into account before a decision is taken to award an interim injunction against a generic drug manufacturer (a so-called infringer) who manufactures and sells a generic version of a life-saving patented drug (having the same or at least substantially the same composition as that of the composition patented by the patentee) to a substantial population of the country.

In this respect, Justice Bhatt went ahead to observe in the Roche v Cipla judgment that “Between the two competing public interests, that is, the public interest in granting an injunction to affirm a patent during the pendency of an infringement action, as opposed to the public interest in access for the people to a life-saving drug, the balance has to be tilted in favour of the latter.” This logic makes more sense when prima facie it appears that such generic manufacturer manufactures and sells their version of the patented drug at a much lower price, say for example, at almost one-third the reported price of the patentee’s drug.

However, one wonders whether the repercussion of the Roche v Cipla order will be that with respect to every case relating to infringement of an essential life-saving patented drug, a legitimate patentee invariably will be not awarded the benefit of interim injunction merely because an infringer manufactures and sells a version of the patentee’s patented drug at a price lower (not necessarily much lower) than the actual price of a drug being sold by the patentee. The question is when a lower price of a generic drug is sufficiently low to be considered to have qualified to hamper the interest of the public? If one-third the price of the patented drug has been considered too low, how about one-half or even two-thirds the price of the patented drug?

On the other hand, it is not too much to ask if one argues that a well-reasoned, good decision such as the order of Justice Bhatt in Roche v Cipla should be based on more concrete, tangible evidence and preferably, well-documented information or data or statistics (which are understandably difficult to procure) regarding the percentage of population which would de facto be severely affected if the generic version of a particular life-saving drug suddenly became – because of the interim-order – not available to the public at large than on presumptions that public interest would in general be harmed. A delicate balance between the right of an individual and/or a company to enforce his patent right and rights of people in general to have access to medicine has to be established but that has to be done only on the basis of tangible evidence and not presuppositions or emotional rhetoric.

Moreover, the four-step test – the fourth step being public interest – ought to be invoked only in situations where a life-saving drug or medicine is involved and NOT with respect to any and every pharmaceutical product or chemical composition. For instance, with respect to a patent involving dietary supplement(s) or ancillary medicine(s), it is not very difficult to conjecture that the interest of the public would NOT be hampered as substantially if such product(s) becomes unavailable in the same price range (presuming prices of the generic variant of a product is almost invariably much lower than the price of a patented product) in which a generic company sells it. In situations where life-saving drugs are not involved, applying the age-old and time-tested three-step test (laid down in the American Cyanamid case) should be perfectly alright.

On a different note, wouldn’t it be really interesting to see how the things shape up on the issue of rendering compensation or issuing damages incurred by the aggrieved party (say, a legitimate patentee) in the due course of time. Furthermore, would the trend to make the generic company – manufacturing and selling their version of a patented drug – pay the patentee a royalty (as a particular percentage of the sale or profit made by them) as compensation be also adopted invariably by the courts across India? No need to mention that this trend, if followed invariably, will be more or less in the nature of compulsory licence wherein a licensee pays royalties to a patentee after the grant of a compulsory licence. Is it not that this trend, if continued, in turn would create a court-made compulsory licence regime even though provisions for compulsory licensing already exist in Sections 84, 92, 92 A etcetera of the 1970 Patents Act.

It would also be interesting to see if the amount of royalty the court eventually directs a generic company to pay (if the patentee eventually wins the infringement proceeding) would be a fixed percentage of sale or profit made irrespective of the specifics and circumstances of a case in question (uncanny it would be then) or such royalty would be decided on a case-to-case basis after due consultation with the generics company and more importantly, with the patentee.

There is a further issue, which will keep intriguing many among us. If subsequent to the awarding of an interim or an ad-interim injunction, the actual case of infringement – decided on the basis of the merit of a case – goes on for, say, a couple of years and the decision is eventually awarded in favour of the patentee, would the consequence of such a win actually be sweet enough for the patentee.

Let us attempt to dig on this issue a little. As many Indian attorneys are aware, the grant of a patent on an Indian patent application takes almost five to six years from the date of filing of such application. Recently, though, there has been some remarkable progress by the Indian Patent Office on this front. Post 2007, with respect to some of the relatively recently filed cases, letters for patent documents (patent registration certificates) were issued in some instances within a fortnight from the date of allowance of an application.

Barring the recent outstanding developments, the effective term of a patent in India is in general limited to fourteen to fifteen years (if you are lucky enough not to have been bombarded with pre-grant oppositions before the grant of a patent and then subsequently with post-grant oppositions). Deduct another five to six years for litigation (threat to institute suit, suit for infringement, counter-claim of invalidation, interim orders, decision reserved and eventually, the final judgment/decision) from the effective term and you are actually left with only nine to ten years of effective term.

One does not need to be a rocket scientist to infer that by the time the rights are eventually decided in the favour of say, for instance, a patentee, the patented drug would have perhaps become obscure or would have gained the status of being a drug which is no more in demand. It is not unlikely that the third, fourth or even nth generation(s) of such drug (including the generic variants) would have already flooded the market. The patentee would thus be left with a situation wherein even though it has been restored the exclusive right to manufacture, offer for sale, sell and export its patented drug, it has no more been left with a potential market. A remote consolation for the patentee could be, however, that it would end up earning royalties, which will ostensibly be only a small percentage of what the patentee would have earned if they had retained their privilege, inter alia, to sell and/or market their patented product exclusively for a term of five to six years (i.e., post the grant of the patent).

To sum up, it appears prima facie that the introduction of the fourth step (of public interest) in infringement jurisprudence is a some win (for the generics), some (read much more) lose (for the patentee) situation for the patent infringement litigating parties but is perhaps the beginning of an all win-win situation for at least the consumers.

Swarup Kumar

Swarup Kumar is a senior IPR Associate/Attorney with the IP law firm Groser & Groser in India, where he has worked since February 2004. During Swarup’s stint as a patent attorney, he has handled, inter alia, drafting of complete specification, rendering opinions on the patentability of inventions related to different fields of technologies, filing and prosecution of patent applications, attending to hearings – both application as well as opposition, handling patent litigation matters etc. Swarup is qualified as an advocate and is a registered patent agent. He completed his LLB in 2003 after graduating in chemical and biological sciences from the University of Delhi. Swarup then pursued a diploma course in intellectual property law from the Indian Law Institute, Delhi along with a certificate course in IP with the World Intellectual Property Organization (WIPO) Academy. Subsequently, Swarup also added an MSc (Chemistry) degree from the MP Bhoj University to his educational qualifications. Though Swarup’s thrust area of practice is patent, he also handles trademark, design and copyright related matters in his present position.

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Comments

  1. Kamakhya Srivastava says

    Roche – Cipla Revisited – Much water has flown down river Yamuna since the decision on the interim application of Roche to injunct Cipla from manufacturing and selling ‘Erlocip’, the generic version of Roche’s patented drug ‘Tarceva’. Justice Ravindra Bhatt of Delhi High Court handed out a judgment, as Patent Attorneys describe it, truly innovative and path-breaking. I do not differ from their opinion but many of them, as evident from their writings, have only looked only at the surface rather than finding out the crux behind the judgment. Many small rivulets gurgle down to join a water body to become an inalienable part of it. Metaphorically the issue of consumer interest and pricing has now become, in the interim stage, a part of precedent but surprisingly no comment came on why the Court went into factoring the imponderables like critical cure, accessibility and the price difference between the drug’s patented and generic version. The Indian patent scheme creating the judgment is there like the placid depths of water but unnoticed. It is like the active surface activity of public interest commandeering the limelight.

    The judgment is reflective of the connection between ‘presumption of validity’ and ‘scope of defence’ inherent in the Indian Patents Act.

    There is an absence of presumption of validity of a patent with the availability of the grounds of revocation of a patent as grounds of defence in a patent infringement suit. The absence of presumption of validity only strengthens the defence ground of patent invalidity but is not a cause of its origin. Even if there is a presumption of validity the scope of defence is intact with its ground of patent invalidity. The present patent scheme, in the event of a counterclaim of patent invalidity puts the onus on the patentee to prove it valid. A presumption of validity of a patent shall put the onus on the defendant to prove the patent invalid.

    Section 107(1), the scope of defece in a patent infringement suit, in its wording is unique in as much as there seems to be a double headed arrow between revocation and infringement. The present patent scheme seems to incorporate the grounds governing administrative action (patent revocation) into litigation in courts (infringement suit). The scheme at present seems to allow a person to infringe a patentee’s right first and then aid himself with the defence of patent invalidity.

    The presumption of validity or absence of it runs co-terminus with the scope of claim and there is no reversal of the general position of plaintiff to prove his plaint. The question which, I think, the Court tried to look at is that – Is the Patent Act, in not warranting the validity of any patent coupled with the ground provided under section 107(1) giving a leeway to the infringer to infringe first and then make a counterclaim of patent invalidity in a suit for infringement. Cipla made the counterclaim of patent invalidity only after launching the ‘Erlocip’, the generic version of Tarceva. Due to an absence of presumption of validity of a patent the Court had to prima facie look into the counterclaim of patent invalidity with the same insight as that of the infringement claim of Roche. Finding both the parties equally well positioned (prima facie) the Court went towards factoring imponderables like consumer interest and pricing to judge the balance of convenience. Had there been a presumption of validity the decision on the interim application certainly would have gone into the favour of Roche and on the point of patent invalidity counterclaim, the Court would have remanded the matter back to the Patent Office to look again into its patent grant. The facts of the Roche – Cipla case suggests that section 107(1) dilutes further the effect of grant of a patent.

    Certainly Cipla took a well calculated risk after (may be) getting an insight into the granted claims to Roche and choosing to argue patent invalidity in an infringement suit rather than in a patent revocation proceeding.

    Cipla’s calculation finally paid off because the Court found it prudent not to go into the details of the technicalities at the interim stage, instead factor the imponderables like consumer interest. Some decisions of Gujarat High Court are evident enough of courts getting into the issue of novelty, non-obviousness and utility (the patentability criteria) in deciding interlocutory applications. I think the interplay of the ‘American Realist Theory’ has a lot to do in the Roche – Cipla interim decision.

    Reply

  2. Anubhav Sharma says

    Dear Swarup,

    A nice piece indeed! In fact, most of the issues raised by you in this article bother many among us. However, what troubles me most is dilemma that a trend might be established that an infringer company would blatantly violate a granted patent, i.e. manufacture and sale a patented drug and get away with it by citing the so-called fourth step (of taking care of public interest) with respect to essential pharmaceutical products. I also agree with your take how low a price is low enough?

    On the other hand, I believe that it might not after all be as much all win-win situations for the consumers. If two-third price (2/3rd of 2000$ is 1333.4) is considered low enough price by the courts, I wonder how much advantageous would it be for the public in general who could afford neither of the prices.

    Best wishes.

    Anubhav Sharma

    Reply

  3. Mark Taylor says

    Dear Sir,

    This article by Mr. Kumar appears to be a well-written piece.

    From whatever little knowledge I have of Indian patent law, it is my opinion that in specific instances, consumers interest ought to be taken care of by the courts while deciding the issue of interim injunction – as has perhaps rightly been done in Roche V Cipla judgment. At least the American infringement jurisprudence has been so since a long time now.

    Having said that, in my opinion, until unequivocally proved other wise, a granted patent is still valid and therefore, the rights of the patentee, among others, to manufacture and sale its patented product remains exclusive. There are of course provisions for opposition and further opportunity to claim for invalidity of patent in a court but until these claims are settled, the right of the patentee to exclusively enjoy the fruits of its valid patent is almost sacrosanct.

    In this respect, I agree that a dangerous trend might be set that every valid patent will first be infringed and then by merely raising the rhetoric of public interest every interim injunction will also be evaded by the infringer. This trend will surely dissuade a foreign company to secure grant of patent in India. Perhaps only with respect to life saving drugs, which are clearly used substantially in India, this approach of invoking four-step test could be useful.

    In addition to this, in my opinion the spirit of the law ought to be given more importance than merely vesting emphasis upon the loopholes of legislation or its letters.

    Regards,

    Mark Taylor

    Reply

  4. Sarmistha Banerjee says

    Hi,

    Swarup’s piece is, in my opinion, a well-balanced article which covers almost all the aspects involved vis-à-vis the impact of Roche order’s inclusion of a further step of public interest for deciding interim injunctions.

    From the review of the Roche V Cipla order, it seems that the most important factor which weighed in the mind of the judge – as has also been stressed upon by Swarup – was the issue of (hampering) of public interest. Frankly speaking, the first two tests of American Cyanamid very well appear to have gone in favour of Roche (the patentee). The third test of hardship was unfortunately, not raised and/or argued by the Roche’s attorneys in the court. Of course, the business and litigation strategy of the defendants also played a major role in the eventual out come of the interim order but that is subsidiary to the main legal issue.

    Merely having further opportunities to challenge the validity of a patent in revocation proceedings (Section 64) or in a court (Section 107) does not suo motu leads to inference of absence of presumption of validity of a patent essentially when the Roche patnet was successfully defended in a pre-grant opposition proceeding before the Controller. One should not forget that the prima facie doubts, even if they exist, does not take away the rights conferred upon patentee under Section 48 of the Indian Patents Amendments Act, 2005. Additionally, the relief of (a) interim injunction or /and (b) damages or account of profit, which is codified in Section 108, is a matter of right for the patentee once infringement is proved unequivocally. In order to concretize the presumption of validity of a patent, a formidable challenge has to mounted against the validity of a patent based on the worthiness of one or more grounds laid down inter alia in Section 64 of Indian Patents Act.

    I quote certain specific portions from Justice Bhatt’s interim order incorporating therein at the relevant portions my comments, which will to a large extent, establish – in contradistinction to the emphasis added by someone in the preceding comments – that the ground of public interest played the most crucial role in tilting the decision towards defendants favour.
    “The office of the Controller of Patents found that sometimes the modification in the prior art technologies, which seem minor, can bring great revolutions in the world never otherwise predicted by the society of intellectuals. He concluded as follows:
    A substitution of Group alkynl at metha position of phenyl moiety of known basic compound (i.e. substitute phenyl aminoquinazolines derivative) has brought revolution in the treatment of NSCLC and Pancreatic Cancers and proved its efficacy as compared to the drugs available in the prior Article The Journal clinical oncology, Volume 25 No. 15, May 2007, volume 24, No. 24, August, 2006 may be referred to look into all the facts. The compound appears to be much more effective as compared to the compounds for the similar purpose. None of the prior art citations therefore are able to establish any motivating factors to the persons skilled in the art by looking into the prior art and their appears no possibility of anticipation of such a great improvement in the properties of the invention and invented new derivative compounds. The same thing appears to the allegation of compounds about the structure of the new derivative compound. Such a structural similarity as deduced by far a compound having great medicine value may not be accepted to establish the new derivative as obvious.
    Therefore, I hereby held that the product as claimed in claim I and the process as claimed in claim 2 both are innovative and non obvious. Moreover, the patent office of various advanced countries have examined this invention for novelty and inventions are found. Presence of inventiveness and novelty in the invention (sic). These countries have issued the patent on this invention. Form ‘ 3 filed in patent office discloses this fact.’
    As to whether the invention was in respect of a derivative that disclosed significant enhancement in efficacy, the patent office, in the said order observed as follows:
    The opponent during the hearing raised the issue that the present compounds fall under Section 3(d) of the Indian Patents Act as the claimed compounds are obvious variants of prior art compounds and do not significantly differ in therapeutic efficacy over the compounds of prior Article This issue was not taken in their representation. The applicants submit that the providing of efficacy data at filing was not possible. However, the same has been given as and when asked by Controller. The data regarding survival rate increase has been significantly increased as indicated in the Journal the Oncologist, 5.2.2007. In view of the fact that the opponents have not substantiated and elaborated this ground of objection further once the invention has been found inventive the invention cannot be patentable under Section 3(d) of the Patents Act. Moreover, the opponents have not properly established this ground. Therefore, I held that the invention cannot be held non-patentable under Section 3(d) of the Patents Act, 1970. (sic)”
    “71. From the above discussion a few distinctive factors require to be prima facie considered by This Court. Firstly, whether the Plaintiff’s claim and the patent as granted, involves an inventive step; and, whether it satisfies the test of non-obviousness and further, whether the patent for Erlotinib even if it is a Quinazolin derivative can nevertheless be patentable as there is significant enhancement in known efficacy. Here, the factors which weigh in favor of the plaintiffs claim for prima facie merits or that it has an arguable case, are that it’s claim received the patent office’s examination at two levels i.e. before the grant of patent and during the pre-grant position; a series of medical and Oncological publications which credited Erlotinib with some degree of success in treatment of NSCLS. Some of the publications indicated that the patients had an increased potentiality of survival, of 6.7 months in the case of Erlotinib, as opposed to 4.7 months in the case of placebos. These were, however, after 2005. The drug has also been admittedly produced. There is no serious dispute in that regard; it can therefore be said to have industrial application.”
    “72. In the above background what has to be considered is whether the Defendants have been able to outline a credible or arguable challenge to the Plaintiff’s patent. The Defendant’s objections are principally twofold, that is, that the product was obvious to a person skilled in the prior art and that since Erlotinib is a derivative of a known compound, the Plaintiff had to necessarily establish a significant enhancement in its known efficacy for its claims under Section 3(d).”
    “77. ……………………………………………………………There is also some merit in the plea that comparative data regarding efficacy of the plaintiff’s drug, with existing drugs, was not independently shown at the time of examination of the claim, to establish difference, significantly in regard to its efficacy from the known substance or derivative. (As far as Indian patent practice is concerned, the Indian attorneys generally do not produce such efficacy data to the Patnet Office at the examination stage unless an objection under Section 3 (d) had been raised or the Examiner or Controller had specifically asked to produce such efficacy data. How can an applicant be blamed for that?)”
    “78. On a conspectus of all the factors, the defendant’s contention does not appear implausible. This is not to say that there is merit in its contentions; it is, not also meant to be reflective of the strength of such contentions. Any comment by the court, in that regard would be unfair to the plaintiff. The court should refrain from conducting a mini trial as to the strength of the parties, at the interlocutory stage. All that can be therefore said is that the plaintiff’s case though arguable and though disclosing prima facie merit, has to answer a credible challenge to the patent, raised by the defendant. (Prima facie merit had surely been established in favour of the patentee by a person skilled in the art, i.e., the Controller of Patents. )
    The damage or injury that would occur to the plaintiff in such case is capable of assessment in monetary terms. However, the injury to the public which would be deprived of the defendant’s product, which may lead to shortening of lives of several unknown persons, who are not parties to the suit, and which damage cannot be restituted in monetary terms, is not only uncompensatable, it is irreparable. Thus, irreparable injury would be caused if the injunction sought for is granted.”
    “79. The application of the American Cyanamid principles would then, at this stage, mean that the court should, in such cases, proceed to decide on the question of balance of convenience. This is necessary because the plaintiff has made out an arguable case; at the same time, the defendant’s challenge is genuine. (First the defendant goes to press and declare that it would violate the patentees patent by manufacturing and selling the generic version of its patented product and then goes ahead and actually does so. This was followed by the obvious step of challenging the validity of patent of the patentee and still defendants challenge is GENUINE). Even otherwise the aspect of balance of convenience should be gone into, if the plaintiff has a case on the merits. The House of Lords had with remarkable prescience refrained from attempting to list all the various matters which need to be taken into consideration and deciding where the balance of convenience lies, let alone to suggest the relative weight to them; those factors would vary from case to case. While considering the issue of balance of convenience. This Court has to consider the following factors:
    i) The extent to which disadvantages to each party (Public was certainly NOT a direct party to the suit) would be incapable of being compensated in damages in the event of his succeeding at the trial;
    ii) The nature of the product and its use (Life saving drug)
    iii) The timing of the action (After launching the generic product violating the plaintiff’s product)
    iv) If the balance is approximately equal, the court may consider the relative strength of each party’s case only where it is apparent by undisputed evidence that the strength of one party’s case is disproportionate to that of the other party.”
    “80. It would now be relevant to consider the various factual aspects other than the patent claims of the plaintiff. It is asserted on its behalf that the drug has been made available since the year 2006 by it and has till date recorded sales worth Rs. 13.2 crores. The plaintiff does not have a manufacturing facility in India; it imports Tarceva. It is unclear — since no claim in that regard has been made, as to the marketing arrangements of the plaintiff for its product or its advertisement and other incidental expenses for Tarceva. The plaintiff asserts that one of its tablet costs Rs. 3200/- and that the effective treatment with the drug involves its use for two months, the patient taking the tablet once a day. The Defendant contests this and has produced packaging of the plaintiff and copies of bills disclosing the particulars of Tarceva, as costing Rs. 48,000/- per strip of 10 tablets. It has also produced bills from three pharmacists in different cities i.e. Chennai, Ahmedabad and Mumbai showing that the maximum retail price of its product Erlocip is Rs. 1600/- per tablet. The defendant has also produced a copy of the Central Government Standard Drug Control Organization permission in Form 46 under the Trade and Cosmetics Act, dated 19.10.2007 permitting it to manufacturing Erlocip for the treatment of non-small lung cancer.”
    “81. As observed in a preceding part of this judgment the consistent trend of courts in deciding applications seeking interim injunction, involving claims for infringement of PATENTS have been to be proceed with caution. As noticed earlier, this is more a rule of prudence than one of principle. Thus, unlike in cases involving infringement of other products, the Courts have to tread with care whether pharmaceutical products and more specifically life saving drugs are involved. In such cases, the balancing would have to factor in imponderables such as the likelihood of injury to unknown parties and the potentialities of risk of denial of remedies.”
    “37. Balance of convenience has also an important role to play. Stultification of defendants’ investment, loss of employment, public interest in the product (such a life saving drug), product quality coupled with price, or the defendant being smaller in size, may go against the plaintiff. (What about taking note of the irreparable loss caused to the plaintiff due to non-allowance of enjoyment of its exclusive right to enjoy its patnet for the effective term of its patnet?. How such losses could be exactly be calculated without prejudice to the plaintiffs interest?)”

    The analysis of the above-quoted portions reveals that although the other factors were taken into account, what effectively tilted the case in favour of Cipla was the price issue. Also the Roche’s granted patent being arguably effectively less than six years old also appeared to have played role in this.
    Therefore, even though some water has flown down river Yamuna since the Roche judgment, it is still worth analyzing and criticizing – as has been done by Swarup – a landmark decision like Roche v Cipla of Justice Bhatt. Additionally, the title of the article was “Impact Of The Probable Incorporation Of An Additional Step (Of Public Interest) In Indian Injunction Jurisprudence” and not the “ Why and how the Roche V Cipla judgment was arrived at” .
    Good job Swarup. Please keep the good work up.

    Sarmistha Banerjee

    Reply

  5. Shaline Chopra says

    Dear Swarup,

    A very through article which covers almost all the possible aspects of the impact of possible incorporation of “public interest” as a further test for granting or non-granting of an interim injunction.

    The various possible situations covered in the article with respect to the result of such inclusion of the step of public interest for both the generic company and essentially, the patentee is quite elaborate and scholarly. If the nth generation of a medicine, its efficacious variants and generics are launched in the market until the final disposal of a patent infringement case, that could surely be a big set back for the patentee and the amount of loss incurred by the patentee might not be possible to be compensated at least adequately monetarily or otherwise.

    Regarding the interest of the public in general, I agree with your observation that they are the ones, besides the generic company, who are going to benefit the most from this line of thinking. As long as the price difference between the patented drug and the generic variant remains huge i.e., more than or at least equal to 1/3 rd the original price and the quality of the medicine is not compromised, the consumers will have the last laugh. In some instances, the 1/3rd price might not as well be affordable to public in India but such lower pricing by generics will certainly put pressure on the foreign patentees to keep the price of their patented medicine at a reasonable level.

    On a different note, your information that the Indian Patent Office has geared up to issue letters patent documents within a fortnight of the allowance of an application was an eye opener.

    We hope to see some more pieces from you in future.

    Best wishes,

    Shaline Chopra

    Reply

  6. SEKHAR BANDHOPADHYAY says

    Hi,

    I think Mr. Kumar’s article is an interesting read.

    Perhaps, grant of interim injunction against a generic company which has launched an invalidity objection would have been harsh primarily, when the drug “Tarceva” and its generic version “Erlocip” are vital life-saving cancer drugs. Also, it comes out from the media reports that other equally potent drugs are not available in Indian market. I go with Justice Bhatt’s well-reasoned order which has in some of the paragraphs of the interim order itself made it impliedly clear that the fourth test of “public interest” ought to be raised when essential life-saving drugs are involved.

    As long as this precedent is not made gerneric (by the courts) by applying it to general purpose drugs, this test could serve the interest of general public provided that the price at which the generic version of life saving drugs is launched is actually low enough. How low is low has perhaps to be decided on a case by case basis by the judges.

    In the present context, possibly the time has come to bade good bye to the presumption that patents which are less than six-years old, are not strong patents. Good patents are as much valid and enforceable when they are new, as when they are old. Moreover, it is my belief that the person who decides the validity of a patent against invalidity challenges ought to be more a technical person and than merely a judicial person.

    Some of the above-points have aptly been covered by Mr. Kumar in his well-balanced article. The best part about this piece is that the impact of the interim order has been dealt with in relation to the patentee, the generic company as well as the general public’s point of view.

    I wish Mr. Kumar all the best.

    Dr. Sekhar R. Bandyopadhyay

    Reply

  7. Swarup Kumar says

    Dear readers,

    Thank you very much for expressing so much interest in this piece.

    Frankly speaking, I did not expect comments containing such deep legal, socio-political and technical analysis to appear under this column. My sincere gratitude extends to Dr. Bandopadhyay, Ms Banerjee, Mr. Taylor, Ms Chopra and Mr. Sharma for their positive comments and constructive criticism. I cannot agree more with each of their comments which were genuine, scholarly.

    I am thankful to Mr. New (Editor-in-chief of IP WATCH) for considering and publishing this piece in his esteemed journal.

    On my part, I shall endeavor to write better and varied pieces in the future and shall look forward to receiving your comment and/or criticism.

    Kind regards,

    Swarup Kumar

    Reply

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